This study compared time to meaningful relief from pain after intake of Ibuprofen versus mefenamic acid following surgical removal of teeth; compared the peak effect, over-all assessment of 2 drugs and describe occurrences of adverse events among patients.
Method:
An open- label, randomized, controlled trial evaluating analgesic effectiveness of Ibuprofen 400 mg Soft-Gel Capsule compared with Mefenamic Acid 500 mg Fast-release Capsule for relief of dental pain. Total of 480 patients included, 15 - 50 years old, male/female, underwent surgical removal of posterior teeth (at least 2), multiple extraction of anterior teeth and surgical removal of third molars. Patients had VAS score of not less than 5 and signed the consent form.
Result:
Patients given ibuprofen after dental surgery was comparable to group given Mefenamic acid with respect to socio-demographic characteristics, number of teeth extracted, duration of surgery, baseline pain intensity. Mean pain intensity score of both groups decreased exponentially with time from intake of medication, 60 minutes post-treatment, 2.9% of all patients -3.3% ( Ibuprofen), 2.5% (mefenamic) had pain scores higher than zero - Mefenamic acid- statistically higher at all time points from 5 until 30 minutes after drug intake vs. Ibuprofen. Mean pain relief score and pain intensity difference of both groups increased, Pain relief score within first 30 minute was higher in Ibuprofen than Mefenamic acid, differences not statistically significant. Pain intensity difference was significantly higher for the Ibufropen group until 20 minutes. No adverse events occured. Ibuprofen is non-inferior to Mefenamic Acid based on comparison of time to meaningful relief (non-inferiority margin for hazard ratio- 0.34 to 1.3) maximum/peak effect (non-inferiority margin of -2 to +2), global assessment scores for effectiveness (non-inferiority margin of -1 to +1).
Conclusion:
Ibuprofen is non-inferior to mefenamic acid in terms of analgesic effectiveness after surgical removal of teeth.